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Biotherapy for chronic liver disease

Biotherapy for chronic liver disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-16008255
Enrollment
Unknown
Registered
2016-05-17
Start date
2015-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Interventions

Bacteria Transplantation Group:Bacteria Transplantation
Control Group:Oral Antiviral Therapy

Sponsors

Zhongshan Hospital Affiliated to Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 18~70 years old with HBeAg positive CHB; Underwent more than 3 years of antiviral therapy whereas HBeAg remains positive; Ongoing ETV or TDF based antiviral therapy; HBV DNA levels <10, 000 IU/mL; Alanine aminotransferase (ALT) levels <80 U/L; Subjects who have using interferon or pegylated interferon with the last dose at least 24 weeks before screening

Exclusion criteria

Exclusion criteria: Alcoholism; Genetic or metabolic liver diseases, such as Wilsons disease, hemachromatosis, etc. Co-infection of HAV, HCV, HEV, EBV and CMV; Concurrent malignant tumors; Autoimmune liver diseases; Liver cirrhosis with decompensated liver function; Pregnant or lactating women; Concurrent conditions that is contraindicated for endoscopy; A ceased previous history in the past 26 weeks of using interferon or pegylated interferon

Design outcomes

Primary

MeasureTime frame
HBeAg Clearance;

Secondary

MeasureTime frame
Decline of HBeAg Titer;The structural and quantity alterations of intestinal flora pre- and after fecal transplantation;

Countries

China

Contacts

Public ContactJin-Shui Pan

Zhongshan Hospital Affiliated to Xiamen University

363111396@qq.com+86 13666083256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026